MAUDE Adverse Event Report: BARD ACCESS SYSTEMS DECATHLON W/STYLET 15.5 FR. STR, TIP-CUP 23CM; LONG-TERM HEMODIALYSIS CATHETER

Model Number	DF23SH28K
Medical Device Problem Codes	Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot number for the device was provided.The device history records are currently under review.The device has been returned for evaluation.The investigation is currently underway.(expiration date: 09/2020).
Event or Problem Description
It was reported that approximately within twenty one days of the dialysis catheter placement, an alleged split at the hub of the catheter and a fluid leak was identified.It was further reported that the patient was unable to receive the dialysis due to a fluid leak.Reportedly, an additional intervention was required for removal and replacement of the device.It was further reported that the patient resumed dialysis after the removal and replacement of the device.
Additional Manufacturer Narrative
Manufacturer review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one 23 cm decathlon df catheter was returned for evaluation.Functional, gross visual, microscopic visual and tactile evaluations were performed.The investigation is confirmed for external leak/partial fracture, as a partial split was observed on the red hub extension leg just proximal to the bifurcation.Leaking was observed at the split when the red hub was infused and the split surface was observed to be rough.Varying amounts of material that resembles adhesive material were found throughout the split.The definitive root cause could not be determined based upon available information.Repeated/excessive stresses and/or torques, incorrect clamps, and/or exposure to cleaning solutions may have contributed to the reported event.However, it is unknown if procedural issues contributed to the reported event.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) showed that the product labeling is adequate.
Event or Problem Description
It was reported that approximately within twenty one days of the dialysis catheter placement, an alleged split at the hub of the catheter and a fluid leak was identified.It was further reported that the patient was unable to receive the dialysis due to a fluid leak.Reportedly, an additional intervention was required for removal and replacement of the device.It was further reported that the patient resumed dialysis after the removal and replacement of the device.

• Brand Name: DECATHLON W/STYLET 15.5 FR. STR, TIP-CUP 23CM
• Common Device Name: LONG-TERM HEMODIALYSIS CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8670936
• Report Number: 3006260740-2019-01551
• Device Sequence Number: 16214482
• Product Code: MSD
• UDI-Device Identifier: 00801741013966
• UDI-Public: (01)00801741013966
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K033294
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: DF23SH28K
• Device Catalogue Number: DF23SH28K
• Device Lot Number: RECZ2631
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2019
• Initial Date Received by Manufacturer: 05/09/2019
• Supplement Date Received by Manufacturer: 07/17/2019
• Initial Report FDA Received Date: 06/05/2019
• Supplement Report FDA Received Date: 07/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR